Date: 2015-01-19
Type of information: Granting of a Market Authorisation in the EU
Product name: Exviera®
Compound: dasabuvir
Therapeutic area: Infectious diseases
Action mechanism: direct-acting antiviral agent/NS5B RNA polymerase inhibitor. Dasabuvir is a non-nucleoside inhibitor of NS5B viral RNA-dependent RNA polymerase.
Company: Abbvie (USA - IL)
Disease: chronic hepatitis C
Latest news: * On November 21, 2014, the Committee for Medicinal for Human Use (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Exviera® (dasabuvir) for the treatment of chronic hepatitis C virus (HCV) infection in adults in combination with other medicinal products for the treatment of chronic hepatitis C. Exviera® was evaluated under EMA’s accelerated assessment mechanism, a tool which aims to speed up patients’ access to new medicines where there is an unmet medical need.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2015-01-19
Favourable opinion UE: 2014-11-21
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
